ATALA BIO HAND SANITIZER- didecyldimonium chloride and benzalkonium chloride liquid gel 
Kemix Quimica, S.A. de C.V.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredient(s)

DIDECYLDIMONIUM CHLORIDE 0.25 % v/v. Purpose: Antiseptic

BENZALKONIUM CHLORIDE 0.1 % v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Avoid Eye Contact.Flammable. Keep away from heat or flame. Do not ingest

Do not use

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

glycerin, purified water USP, MAGNESIUM DISODIUM EDTA, ISOPROPYL ALCOHOL,METHYL ALCOHOL

Package Label - Principal Display Panel

4 L NDC: 77396-050-01

4L

250 mL (0.25 L) NDC: 77396-050-03

250 mL

75 mL (0.075 L) NDC: 77396-050-02

75 mL

ATALA BIO HAND SANITIZER 
didecyldimonium chloride and benzalkonium chloride liquid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77396-050
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA) DIDECYLDIMONIUM CHLORIDE2.5 mg  in 0.001 L
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 0.001 L
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYL ALCOHOL (UNII: Y4S76JWI15)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77396-050-014 L in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/01/2020
2NDC:77396-050-020.075 L in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/01/2020
3NDC:77396-050-030.25 L in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/01/2020
Labeler - Kemix Quimica, S.A. de C.V. (813182128)
Registrant - Kemix Quimica, S.A. de C.V. (813182128)
Establishment
NameAddressID/FEIBusiness Operations
Kemix Quimica, S.A. de C.V.813182128manufacture(77396-050) , label(77396-050)

Revised: 9/2020
Document Id: af872984-e15b-f533-e053-2a95a90acd5b
Set id: af872984-e169-f533-e053-2a95a90acd5b
Version: 1
Effective Time: 20200917
 
Kemix Quimica, S.A. de C.V.